Unique ID issued by UMIN | UMIN000028762 |
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Receipt number | R000032448 |
Scientific Title | The effect on blood pressure of a rice bran peptide containing foods. - Randomized placebo controlled study- |
Date of disclosure of the study information | 2017/09/14 |
Last modified on | 2018/09/04 16:45:20 |
The effect on blood pressure of a rice bran peptide containing foods.
- Randomized placebo controlled study-
The effect on blood pressure of a rice bran peptide containing foods.- Randomized placebo controlled study-
The effect on blood pressure of a rice bran peptide containing foods.
- Randomized placebo controlled study-
The effect on blood pressure of a rice bran peptide containing foods.- Randomized placebo controlled study-
Japan |
Persons with high-normal blood pressure or mild hype
Adult |
Others
NO
To investigate the improvement of blood pressure of repeated ingestion for 12 weeks of a rice bran peptide containing foods.
Safety,Efficacy
<Efficacy>
systolic blood pressure,diastolic blood pressure
<Safety>
Side effect incidence, Adverse event incidence, clinical examination items, and physiological examination items
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Rice bran peptide non-formulated food, 12 weeks
Rice bran peptide-containing food, 12 weeks
45 | years-old | <= |
65 | years-old | > |
Male and Female
1.Males and females equal to or more than 45 years and less than 65 years of age
2.Subjects who contain 130 mmHg <= systolic blood pressure <= 159 mmHg or 85 mmHg <= diastolic blood pressure <= 99 mmHg
3.Subjects equal to less than 30 kg/m^2 of BMI
4.Possible study volunteer to visit
5.Subjects who recognize the object and contents of the study and submit the written informed consent
1.Pregnant women or breast-feeding women.
2.Individual donated 400 ml of blood within 12weeks or component blood donation 200 ml of blood within 4weeks prior to the study.
3.Individual have already participated other clinical trial or within 4 weeks of examination end.
4.Subjects who have marked impairment of heart,liver, kidney, thyroid, and other diseases.
5.Subjects who have a history of cardiovascular disease
6.Subjects who develop diabetes(Recommended by Japan Diabetes Society).
7.Subjects who have food allergy against brown rice, rice bran, and rice
8.Individual experienced unpleasant feeling by drawing blood in the past.
9.Heavy drinkers
10.Heavy Smokers(More than daily an average of 21 of them)
11.Subjects whose eating habits are extremely irregular
12.Subjects who take medications that may affect this exam
13.Subjects who regularly using foods such as specified health foods and functional display foods that may affect this inspection
14.Secondary hypertension
15.Subjects who have a history of large surgery(gastrectomy, gastrointestinal suture, intestinal resection) on the gastrointestinal except who resect the cecum.
16.Individual who was judged ineligibles by clinician in this trial.
80
1st name | |
Middle name | |
Last name | Motonobu Matsumoto |
Sunstar Inc.
General Manager R&D
3-1, Asahimachi, Takatsuki, Osaka,Japan
072-682-5570
motonobu.matsumoto@jp.sunstar.com
1st name | |
Middle name | |
Last name | Yoshitaka Hatakeyama |
New Drug Research Center, Inc.
Clinical Research Dept.
452-1Toiso,Eniwa-shi,Hokkaido, Japan
0123-34-0412
y-hatakeyama@ndrcenter.co.jp
Sunstar Inc.
Sunstar Inc.
Profit organization
NO
2017 | Year | 09 | Month | 14 | Day |
Unpublished
Completed
2017 | Year | 07 | Month | 18 | Day |
2017 | Year | 09 | Month | 12 | Day |
2017 | Year | 08 | Month | 21 | Day |
2018 | Year | 09 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032448
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